If you or a loved one received a Penumbra JET 7 Catheter and subsequently suffered injuries related to the device, you may be entitled to compensation for your losses through a Penumbra JET 7 Catheter lawsuit.
Contact TorHoerman Law for a free, no-obligation case consultation with an experienced injury lawyer to discuss your legal options today.
You can also use our chatbot to receive a free, instant online case evaluation to find out if you qualify for compensation right now.
The U.S. Food and Drug Administration (FDA) has alerted that Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of an unexpected death or serious injury while used for removing clots in stroke patients.
The devices affected by the recall include:
*Note – The recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
The FDA recommends users follow all instructions provided in Penumbra’s Urgent Voluntary Medical Device Recall Notification:
Lastly, you should report any adverse events or suspected events experienced with the JET 7 Xtra Flex through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
You may qualify for the Penumbra JET 7 injury lawsuit if you or a loved one received a JET 7 catheter device, and subsequently suffered injuries or complications, including:
Contact TorHoerman Law today or use our chatbot below to get a free, instant online case evaluation right now.
At TorHoerman Law, our attorneys operate on a contingency fee basis, meaning that we do not charge legal fees to our clients until after they have been awarded compensation for their JET 7 injuries.
If our clients are not compensated through a settlement or verdict, we foot the bill for all legal costs incurred.
That’s right – if we don’t win your case, then you do not pay any legal fees.
That is our way of guarenteeing to our clients that we only take cases that we believe we can win & that we are as committed as our clients to getting the best possible outcome from their case.
Penumbra’s reperfusion catheter is used by many surgeons in thrombectomy procedures when removing blood clots from the veins and arteries of their patients.
If you have suffered an injury due to this device, you should contact an experienced JET 7 catheter lawyer immediately.
As a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing, the JET 7 Xtra Flex catheter and JET 7MAX configuration (JET 7 Xtra Flex catheter and MAX Delivery Device) are medical devices intended to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke within 8 hours of symptom onset who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or those who fail IV t-PA therapy.
In several reports regarding the device, arterial ruptures led to patient deaths.
In some of these cases, the rupture occurred in the internal carotid artery, which supplies blood to the brain and eyes.
Furthermore, some reported ruptures were associated with damage to the distal tip.
Gabriel Grego, the managing partner at Quintessential Capital Management, published a short thesis calling the Penumbra Jet 7 “unsafe and unmarketable.”
The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including:
Of the MDRs, twenty of them describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event.
Other MDRs describe serious patient injuries such as:
Device failure modes reported in the MDRs include:
Additionally, Bench testing performed by the manufacturer, where the catheter distal tip is plugged and pressurized to failure, demonstrates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters.
If you or a loved one has suffered a Penumbra catheter injury - reporting your injury is the first step in your road to recovery.
Here’s how to do so:
Voluntary reports can be submitted through MedWatch.
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
When possible, reports should include the following information:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
The civil litigation process requires extreme attention to detail and can be overwhelming for someone who does not possess extensive legal knowledge.
A Penumbra JET 7 catheter lawyer will need to be able to prove the liability of another party for any injuries that you have suffered.
If you believe that you may qualify for legal action, contact TorHoerman Law for a free consultation with a JET 7 injury lawyer to discuss your legal options.
You can also use our chatbot below to receive a free, instant online case evaluation right now.
If you do qualify for legal action, there are a few steps that you should take to prepare for your lawsuit:
To mitigate damages is the process in which the injured party minimizes that costs & losses incurred as a result of an accident.
Some important step to mitigation include:
Mitigation is an important step in building a strong & honest case in your favor.
Next, you should consult with an injury attorney to discuss your legal options.
After consulting with at least one attorney, consider the benefits of hiring an injury lawyer to represent you in your JET 7 injury lawsuit.
You can get a free, no-obligation consultation from a THL attorney today.
Remember, the statute of limitations limits the amount of time you have to take legal action after an incident or injury - so do not hesitate to initiate the process and talk to a lawyer as soon as possible.
Hiring an attorney can be a strenuous decision and takes some diligent research.
You should seek legal representation from a lawyer who:
An experienced personal injury attorney can help you in the process of building a strong case and then use their knowledge of the court system to litigate on your behalf.
Some roles of your attorney include:
Your attorney will handle the ligation process so that you can focus on the most important thing, recovery.
At TorHoerman Law, we have won more than $4 billion in verdicts and negotiated settlements for our clients.
Our attorneys have more than a century of combined experience litigating medical device cases.
Our results and expertise speak for themselves.
If you or a loved one have suffered an injury due to this defective product, contact a JET 7 catheter lawyer at TorHoerman Law today to discuss your legal options or use our chatbot below to get a free instant online case evaluation right now!
Commissioner, O. (n.d.). Reporting Serious Problems to FDA. Retrieved January 14, 2021, fromhttps://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
Center for Devices and Radiological Health. (n.d.). Mandatory Reporting Requirements. Retrieved January 14, 2021, fromhttps://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities
Penumbra Recalls Jet 7 Xtra Flex Stroke Catheter Due to Safety Concerns Including Potential Patient Injury and Death. (n.d.). Retrieved January 14, 2021, fromhttps://evtoday.com/news/penumbra-recalls-jet-7-xtra-flex-stroke-catheter-due-to-safety-concerns-including-potential-patient-injury-and-death#:~:text=December%2016%2C%202020-,Penumbra%20Recalls%20Jet%207%20Xtra%20Flex%20Stroke%20Catheter%20Due%20to,Created%20with%20Sketch.&text=The%20company%20says%20that%20distal,subsequent%20patient%20injury%20or%20death.
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